E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced NSCLC not previously treated with chemotherapy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029521 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Efficacy of erlotinib administered as a single agent to chemo-naive NSCLC patients as determined by the Non Progressive Rate (NPR) at 8 weeks. The evaluation will be done in the group of never smokers and current/former smokers separately. |
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E.2.2 | Secondary objectives of the trial |
1. To assess the secondary efficacy parameters as determined by - the objectice response rate and disease control rate - duration of response - time to progression - progression free survival - overall survival 2. To assess biomarker data on tumor specimen collected prior to erlotinib therapy and correlate with erlotinib treatment outcome 3. to prospectely evaluate the PK parameters potentially influencing erlotinib activity in never-smoker and current/former smoker group 4. To study safety and tolerability of erlotinib in a first-line setting |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Patients with histological documented, locally advanced or recurrent (stage RIB and not amenable for combined modality treatment) or metastatic (Stage IV) NSCLC who have not received prior chemotherapy for advanced disease. - Formalin-fixed, paraffin-embedded primary diagnosis lung tumour tissue samples (tissue blocks are preferred over slides) representative of the tumour and collected prior to starting erlotinib therapy will be provided to the co-ordinating investigator within 3 weeks of the patient starting erlotinib therapy. This Is A Mandatory Requirement For Study Entry - No prior chemotherapy for advanced disease . Previous adjuvant treatment is permitted if patient relapsed >_ 1 year after the end of the chemotherapy. - Measurable disease according to RECIST. - Age 18 or greater. - Able to comply with study and follow-up procedures. - Patients must be able to take oral medication. - Written (signed) Informed Consent (WIC) to participate in the study. - ECOG performance status of 0 - 2. - Life expectancy of at least 12 weeks. - At least 4 weeks since any prior surgery or radiotherapy. Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy. - Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3 ; Haemoglobin > 9.0g/dl . - Serum bilirubin within upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) < 2.5 x ULN (or S 5 x ULN in case of liver metastases) . - Serum creatinine <_ 1 .5 ULN or creatinine clearance > 60 ml/min.'' For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy. Patients with reproductive potential must use effective contraception. - Patients that either can be classified as never smokers or as current/former smokers according to the definitions in section 3 .1 (note that all other smokers (e.g. cigar, pipe) will be excluded from study participation). |
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E.4 | Principal exclusion criteria |
- Any unstable systemic disease including: o active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol treatment, o uncontrolled hypertension, o unstable angina, o severe heart disease (NYHA stages III and IV heart failure, unstable angina, uncontrolled arrhythmia in particular) o congestive heart failure, o history of myocardial infarction within the previous year, o serious cardiac arrhythmia requiring medication, o hepatic, renal or metabolic disease, - Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). - Patients are excluded if they have clinical evidence of brain metastasis, or have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded. - Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the study medication. - Previous treatment with any therapy which acts on the EGFR axis. - Patients unable to take oral medication, requiring intravenous alimentation, who have malabsorption syndrome or any other condition affecting gastrointestinal absorption, or who have active peptic ulcer disease. - Nursing and/or pregnant women. - Any inflammatory changes of the surface of the eye. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The two treatment groups in this study will be evaluated separately; no statistical comparison of the results in the two treatment groups is planned. The primary efficacy variable is the Non Progressive Rate (NPR). The NPR is defined as the proportion of patients without progressive disease (PD) (based on RECIST criteria) at 8 weeks after start of treatment, i.e., all patients with either a complete response (CR), partial response (PR), or stable disease (SD) that is documented for at least 8 weeks from baseline. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
caratteristiche pazienti (fumatori e non) |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |